Loading body, loading device and delivery system for housing a valve prosthesis

Abstract

The application relates to the technical field of medical devices, and provides a loading body for containing a valve prosthesis, a loading device and a delivery system. The loading body comprises a first loading part which is retractable, and a second loading part. The first loading part and the second loading part can move away from each other to release the valve prosthesis. The first loading part can be compressed in the axial direction by abutting against the second loading part after the valve prosthesis is released. Through the technical scheme, the operation convenience of medical staff can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to an interventional artificial heart valve delivery system and its components. Background Technology

[0002] Heart valve disease is one of the most common heart diseases in my country, with valvular damage mainly caused by rheumatic fever. In recent years, with the aging of the population, valvular degeneration (including calcification and myxoid degeneration) and metabolic valvular damage have also been increasing in my country. At present, implanting a heart valve prosthesis through minimally invasive medical surgery provides medical staff with a new treatment method that is less invasive, has fewer complications, and allows for faster postoperative recovery.

[0003] During valve treatment, a delivery device is needed to transport, control, and release the prosthetic heart valve. However, the axial dimension of the loading part of the existing delivery device used to load the artificial valve is relatively large. After the prosthetic heart valve is released, when the delivery device is withdrawn during the cross-valve operation, there is a high risk of scraping the implanted prosthetic heart valve and causing displacement. Summary of the Invention

[0004] The technical problem to be solved by this application is to provide a carrier, loading device and delivery system for accommodating valve prostheses that improves the ease of operation.

[0005] To solve the above-mentioned technical problems, this application adopts the following technical solution:

[0006] In a first aspect, this application provides a carrier for accommodating a valve prosthesis, comprising: the carrier including a retractable first loading member and a second loading member, the first loading member and the second loading member being movable away from each other to release the valve prosthesis; the first loading member being able to abut against the second loading member and be compressed axially after the valve prosthesis is released.

[0007] In the implementation of the above scheme, the loading device includes a retractable first loading member and a second loading member. The loading device is used to accommodate the valve prosthesis. When the first loading member and the second loading member move away from each other, the valve prosthesis can be released from the loading device. After the valve prosthesis is released, the first loading member can abut against the second loading member and be compressed axially, thereby shortening the axial length of the loading device, facilitating the retraction of the loading device, and also facilitating the bending of the loading device, improving the convenience of operation for medical staff; when retracting the delivery system during cross-valve operations, the risk of scraping the implanted valve prosthesis is reduced.

[0008] In one embodiment, the first loading member includes a first loading portion located at the distal end and a second loading portion connected to the first loading portion and located at the proximal end, the second loading portion being sleeved on the outer periphery of the first loading portion, and the first loading portion being axially movable relative to the second loading portion.

[0009] In the implementation of the above scheme, the first loading component includes a first loading part located at the far end and a second loading part connected to the first loading part and located at the near end. The second loading part is sleeved on the outer periphery of the first loading part, which is equivalent to the radial dimension of the first loading part not exceeding the inner diameter dimension of the second loading part. The first loading part can move axially relative to the second loading part, so that the first loading part and the second loading part can form a coaxial sleeve structure, thereby realizing the compression of the first loading component in the axial direction.

[0010] In one embodiment, the first loading portion includes a first boss facing one end of the second loading portion, and the second loading portion includes a first tapered section facing one end of the first loading portion, the first tapered section being able to fit against the first boss.

[0011] In the implementation of the above solution, by providing a first boss at the end of the first loading part facing the second loading part and providing a first tapered section at the end of the second loading part facing the first loading part, when the first loading part extends its axial length, the first tapered section can fit with the first boss to form a snap-fit ​​connection, thereby reducing the problem of the first loading part falling off the second loading part.

[0012] In one embodiment, the outer surface of the first loading part is provided with at least one protrusion to prevent the second loading part from falling off, and the protrusion is located at one end away from the first boss.

[0013] In the implementation of the above solution, by providing at least one protrusion on the outer surface of the first loading part, it is possible to prevent the second loading part from falling off the far end of the first loading part during the compression process.

[0014] In one embodiment, the first loading member includes a first loading portion located at the distal end and a second loading portion connected to the first loading portion and located at the proximal end. The first loading portion is sleeved on the outer periphery of the second loading portion, and the first loading portion is axially movable relative to the second loading portion.

[0015] In the implementation of the above scheme, the first loading member includes a first loading part located at the far end and a second loading part connected to the first loading part and located at the near end. The first loading part is sleeved on the outer periphery of the second loading part, which is equivalent to the radial dimension of the second loading part not exceeding the inner diameter dimension of the first loading part. The first loading part can move axially relative to the second loading part, so that the first loading part and the second loading part can form a coaxial sleeve structure, thereby realizing the compression of the first loading member in the axial direction.

[0016] In one embodiment, the second loading portion includes a second boss facing one end of the first loading portion, and the first loading portion includes a second tapered section facing one end of the second loading portion, the second tapered section being able to fit against the second boss.

[0017] In the implementation of the above solution, by providing a second boss at one end of the second loading part facing the first loading part, and providing a second tapered section at one end of the first loading part facing the second loading part, when the first loading part extends its axial length, the second tapered section can fit against the second boss to form a snap-fit ​​connection, thereby reducing the problem of the first loading part falling off the second loading part.

[0018] In one embodiment, the second loading member includes a plug-in section, the radial dimension of which does not exceed the inner diameter of the second loading part, and the plug-in section can be inserted into the second loading part, or the second loading member is sleeved on the outer periphery of the second loading part.

[0019] In the implementation of the above scheme, the second loading component includes an insertion segment. The radial dimension of the insertion segment does not exceed the inner diameter of the second loading part, so that the insertion segment can be inserted into the inner diameter of the second loading part, thereby compressing the axial length of the loading body. At the same time, it also allows the proximal end of the second loading part to abut against the outer periphery of the insertion segment of the second loading component, so that the structure of the loading body is stable under compression and during intervention. Of course, the inner diameter of the second loading component can also be no less than the radial dimension of the second loading part, so that the second loading component is fitted onto the outer periphery of the second loading part, and the axial length of the loading body can be further compressed after the valve prosthesis is released.

[0020] In one embodiment, the first loading member includes a connecting post located at the distal end for connection with the adjustment assembly; the second loading member includes a protruding post located at the proximal end for connection with the first connecting member.

[0021] In the implementation of the above scheme, a connecting post is set to connect with the adjustment component, so that the adjustment component can control the first loading member, which can move the first loading member away from the second loading member to expose the valve prosthesis for easy release, or the adjustment component can control the first loading member to move towards the second loading member; the second loading member includes a protruding post protruding towards the proximal end, which facilitates the connection between the first connecting member and the second loading member, and further enables the first connecting tube to connect with the second loading member through the first connecting member, so that the first connecting tube controls the movement of the second loading member.

[0022] Secondly, this application provides a loading device, including the loading carrier for accommodating a valve prosthesis provided in the first aspect, and an adjustment assembly. The adjustment assembly includes a support member connected to the distal end of a first loading member and adapted to move the first loading member. The support member is connected to the distal end of a first loading portion of the first loading member and can be used to control the movement of the first loading portion relative to a second loading portion. The loading device includes a first connecting tube, one end of which is connected to the proximal end of a second loading member, and the other end is used to connect to a handle. The support member extends within the first connecting tube.

[0023] In the implementation of the above scheme, the adjustment component includes a support member connected to the distal end of the first loading member. The support member can move the first loading member away from the second loading member, further exposing the valve prosthesis within the loading body for easier release. Alternatively, after the valve prosthesis is released, the first loading member can be controlled to move towards the second loading member, causing the second loading member to abut against the first loading member and compress it, thus shortening the axial length of the loading body. The support member is connected to the distal end of the first loading part and can be used to control the movement of the first loading part relative to the second loading part, achieving the elongation or compression of the first loading member and adjusting its axial length. The length facilitates the retraction of the loading device; by setting a first connecting tube, and the support extending inside the first connecting tube, one end of the first connecting tube is connected to the proximal end of the second loading device, medical staff can easily control the second loading device to move toward or away from the first loading device, thereby enabling the first and second loading devices to move relative to each other or away from each other, facilitating the compression of the axial length of the loading device and the release of the valve prosthesis. In addition, the first and second loading devices can move relative to each other simultaneously, shortening the contraction time of the loading device, or move away from each other simultaneously, shortening the release time of the valve prosthesis, thereby further shortening the operation time.

[0024] In one embodiment, the distal end of the first loading part is provided with a positioning groove, the adjustment component includes a fixing member, the support member passes through the loading body in the axial direction, the fixing member is located at the distal end of the support member and is fixedly connected to the support member, the fixing member is located in the positioning groove and abuts against the bottom wall of the positioning groove.

[0025] In the implementation of the above scheme, the far end of the first loading part is provided with a positioning groove, the adjustment component also includes a fixing member, the support member extends in the loading body and penetrates the loading body axially, the fixing member is located at the far end of the support member and is fixedly connected to the support member, the fixing member is located in the positioning groove and abuts against the bottom wall of the positioning groove, the diameter of the support member is relatively small, so the contact area with the first loading part is small. By setting the fixing member and fixing the fixing member to the support member, the contact area between the support member and the first loading part is indirectly increased, and the fixing member is located in the positioning groove, realizing the connection between the support member and the first loading part, which facilitates the support member to control the movement of the first loading part.

[0026] In one embodiment, the fastener and the support are made of the same material.

[0027] In the implementation of the above solution, the fastener and the support are made of the same material, which facilitates welding or gluing the fastener and the support.

[0028] In one embodiment, the adjustment assembly includes a limiting member connected to the distal end of the support member, the limiting member being embedded in the positioning groove and fixedly connected to the first loading part; axially, the fixing member is located at the proximal end of the limiting member.

[0029] In the implementation of the above solution, the adjustment component also includes a limiting member that connects to the far end of the support member. The limiting member is embedded in the positioning groove and fixedly connected to the first loading part. In the axial direction, the fixing member is located at the near end of the limiting member, thereby reducing the problem of the support member and the fixing member coming out of the positioning groove. The limiting member plays a stopping role.

[0030] In one implementation, the limiting member is made of the same material as the first loading member.

[0031] In the implementation of the above scheme, the limiting component and the first loading component are made of the same material, which facilitates the fixed connection between the limiting component and the first loading component.

[0032] In one embodiment, the loading device includes a first connector located near the proximal end of the second loading member and connected to the first connecting pipe and the protrusion of the second loading member, respectively.

[0033] In the implementation of the above scheme, the first connector is located near the second loading component and is connected to the protrusions of the first connecting pipe and the second loading component respectively, which facilitates the connection between the first connecting pipe and the second loading component.

[0034] In one embodiment, the loading device includes a positioning element for positioning the valve prosthesis connection, wherein the first loading element and the second loading element are movable in a direction away from the positioning element, such that the positioning element is axially positioned between the first loading element and the second loading element.

[0035] In the implementation of the above scheme, the loading device also includes a positioning member for positioning the valve prosthesis connection. The first loading member and the second loading member can move away from the positioning member respectively, so that the positioning member is located between the first loading member and the second loading member in the axial direction, thereby realizing the detachment of the valve prosthesis from the loading carrier and facilitating the release of the valve prosthesis.

[0036] In one embodiment, the loading device includes a sleeve connected to the distal end of the positioning member, and the support extends axially through the positioning member and the sleeve.

[0037] In the implementation of the above scheme, by setting up a sleeve, the sleeve provides stable support for the support component, thereby improving the stability of the support component. At the same time, it also improves the concentricity between the support component and the load body, reducing the problem of the support component deviating from its axis.

[0038] In one embodiment, the outer surface of the support member is provided with a heat-shrinkable film.

[0039] In the implementation of the above solution, heat shrink film can reduce the gap between the support and the sleeve, improve the concentricity between the support and the sleeve, and make the support and the sleeve coaxial.

[0040] In one embodiment, the loading device includes a second connecting tube, one end of which is connected to the proximal end of the positioning member, and the other end is used to connect to a handle.

[0041] In the implementation of the above scheme, the loading device includes a second connecting tube. One end of the second connecting tube is connected to the proximal end of the positioning member, and the other end is used to connect to the handle, so that the second connecting tube can control the movement of the positioning member in the loading body, which facilitates the release of the valve prosthesis and improves the convenience of operation.

[0042] In one embodiment, the support extends inside the second connecting tube and has a gap with the second connecting tube. A first gap is provided between the support and the proximal end of the positioning member, and the first gap communicates with the gap. The positioning member is provided with an exhaust hole, and the exhaust hole communicates with the first gap.

[0043] In the implementation of the above scheme, a first gap is provided between the proximal ends of the support and the positioning component. The positioning component is provided with an exhaust hole, which communicates with the first gap. There is a gap between the support and the second connecting tube, which facilitates the relatively independent movement of the support and the second connecting tube, reducing the friction between them. By setting a first gap between the proximal ends of the support and the positioning component, the first gap can communicate with the gap between the support and the second connecting tube. During the operation, air can be vented by injecting liquid between the support and the second connecting tube. The air between the support and the second connecting tube is discharged through the first gap and the exhaust hole on the positioning component, reducing the impact of air on the operation and improving the success rate of the operation.

[0044] In one embodiment, the first connecting tube is sleeved on the outer periphery of the second connecting tube, a second gap is provided between the second connecting tube and the first connecting tube, and the positioning member has a notch in the circumferential direction, the notch communicating with the second gap.

[0045] In the implementation of the above scheme, the first connecting tube is sleeved on the outer periphery of the second connecting tube, and a second gap is provided between the second connecting tube and the first connecting tube. The positioning member has a notch in the circumferential direction, and the notch communicates with the second gap. The diameters of the first connecting tube and the second connecting tube are different. Therefore, there is a second gap between the first connecting tube and the second connecting tube. By setting a notch in the circumferential direction of the positioning member, the second gap can communicate with the notch. During the operation, air can be vented by injecting liquid between the first connecting tube and the second connecting tube. The air in the second gap is discharged through the notch, reducing the impact of air on the operation and improving the success rate of the operation.

[0046] In one embodiment, the loading device includes a guide head connected to the first loading part; the first loading part includes a protruding connecting post with the positioning groove; the guide head has a connecting groove at one end facing the connecting post, the connecting post is threaded to the peripheral wall of the connecting groove, one end of the limiting member is embedded in the positioning groove, and the other end is tightly fitted to the connecting groove.

[0047] In the implementation of the above scheme, the first loading part includes a protruding connecting post with a positioning groove; the end of the guide head facing the connecting post has a connecting groove, the connecting post is fixedly connected to the peripheral wall of the connecting groove, and one end of the limiting member is embedded in the positioning groove, while the other end is tightly connected to the connecting groove, thereby realizing the connection between the guide head and the first loading part and improving the stability of the guide head and the limiting member.

[0048] Thirdly, this application provides a valve prosthesis delivery system, including the loading device provided in the second aspect; it also includes a handle connected to the loading device.

[0049] In the implementation of the above scheme, the handle can control the loading device, thereby realizing the release of the valve prosthesis and the axial shortening of the loading carrier after the valve prosthesis is released. Attached Figure Description

[0050] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0051] Figure 1 This is an exploded structural diagram of the loading device provided in the embodiments of this application;

[0052] Figure 2 Exploded structural diagrams of the loading device provided in the embodiments of this application from different perspectives;

[0053] Figure 3 An exploded structural diagram of the loading device provided in an embodiment of this application from another perspective;

[0054] Figure 4 Another exploded structural schematic diagram of the loading device provided in the embodiments of this application;

[0055] Figure 5 This is a schematic diagram of the loading device provided in the embodiments of this application;

[0056] Figure 6 for Figure 5 A schematic diagram of the cross-sectional structure along the AA direction;

[0057] Figure 7 This is a cross-sectional view of the loading device containing the valve prosthesis provided in the embodiments of this application;

[0058] Figure 8 A schematic diagram illustrating the positional relationship between the valve prosthesis and the loading device during release, provided in an embodiment of this application.

[0059] Figure 9 This is a schematic diagram of the compressed structure of the carrier provided in an embodiment of this application.

[0060] Icons: 1-Carrier; 11-First loading component; 111-First loading section; 1111-Positioning groove; 1112-Connecting post; 1113-First boss; 1114-Protrusion; 112-Second loading section; 1121-First tapering section; 12-Second loading component; 121-Insertion section; 122-Protruding post; 2-Fixing component; 3-Support component; 4-Limiting component; 5-First connecting pipe; 6-First connecting component; 7-Positioning component; 71-Protrusion; 72-Notch; 73-Exhaust hole; 8-Sleeve; 9-First gap; 10-Second connecting pipe; 13-Second connecting component; 14-Second gap; 15-Guide head; 151-Groove. Detailed Implementation

[0061] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0062] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, the term "distal" refers to the end of the delivery system closer to the heart tissue, and "proximal" refers to the end of the delivery system closer to the operator. The terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0063] like Figure 7 As shown, in a first aspect, embodiments of this application provide a carrier 1 for accommodating a valve prosthesis. The carrier 1 is used to accommodate the valve prosthesis and has a telescopic function. When the valve prosthesis is released, the carrier 1 can shorten its axial length, thereby improving the convenience of operation for medical staff and reducing the risk of scraping the implanted valve prosthesis when withdrawing the delivery system during cross-valve operations. In addition, the carrier 1 can also extend to accommodate valve prostheses of different axial lengths, enabling the carrier 1 to adapt to valve prostheses of different specifications and improve adaptability.

[0064] like Figures 6 to 9 As shown, the loading carrier 1 includes a retractable first loading member 11 and a second loading member 12. The loading carrier 1 is used to accommodate the valve prosthesis. When the first loading member 11 and the second loading member 12 move away from each other, the valve prosthesis can be released from the loading carrier 1. After the valve prosthesis is released, the first loading member 11 can abut against the second loading member 12 and be compressed axially, thereby shortening the axial length of the loading carrier 1, facilitating the retraction of the loading carrier 1, and also facilitating the bending of the loading carrier 1, improving the convenience of operation for medical staff; and reducing the risk of scraping the implanted valve prosthesis when retracting the delivery system during cross-valve operations.

[0065] like Figure 5 As shown, since the first loading member 11 is retractable, the first loading member 11 has a multi-segment retractable structure. The loading carrier 1 also includes a second loading member 12, so that the loading carrier 1 in this embodiment can accommodate valve prostheses with longer axial lengths and different lengths compared to the loading carrier 1 with two retractable structures.

[0066] Optionally, the carrier 1 can be made of stainless steel or PEEK (polyetheretherketone), making the carrier 1 a rigid component. This provides higher radial support, reduces the wall thickness of the carrier 1, and thus lowers the radial dimension of the carrier 1. It is also suitable for loading valve prostheses with barbed structures, reducing the risk of puncturing the carrier 1 or the barbs penetrating the carrier 1, which could lead to failure to release the prosthesis.

[0067] like Figure 1 , 2 As shown in Figure 9, in one embodiment, the first loading member 11 includes a first loading portion 111 located at the distal end and a second loading portion 112 connected to the first loading portion 111 and located at the proximal end. The second loading portion 112 is sleeved on the outer periphery of the first loading portion 111, which is equivalent to the radial dimension of the first loading portion 111 not exceeding the inner diameter dimension of the second loading portion 112. The first loading portion 111 is axially movable relative to the second loading portion 112, so that the first loading portion 111 and the second loading portion 112 can form a coaxial sleeve structure, thereby realizing the axial compression of the first loading member 11.

[0068] Optionally, the second loading part 112 is fitted around the outer periphery of the first loading part 111, that is, the radial dimension of the first loading part 111 located at the distal end is less than or equal to the inner diameter of the second loading part 112, so that the mounting carrier 1 can accommodate a valve prosthesis with a smaller distal radial dimension compared to the proximal radial dimension.

[0069] like Figure 1 As shown, in one embodiment, the first loading part 111 includes a first boss 1113 facing one end of the second loading part 112, and the second loading part 112 includes a first tapered section 1121 facing one end of the first loading part 111. When the first loading part 11 extends its axial length, the first tapered section 1121 can fit against the first boss 1113 to form a snap-fit ​​connection, thereby reducing the problem of the first loading part 111 falling off the second loading part 112.

[0070] like Figure 1 and 9As shown, in one embodiment, the outer surface of the first loading part 111 is provided with at least one protrusion 1114 to prevent the second loading part 112 from falling off, and the protrusion 1114 is disposed at one end away from the first boss 1113. By providing at least one protrusion 1114 on the outer surface of the first loading part 111, it is possible to prevent the second loading part 112 from falling off from the distal end of the first loading part 111 during the compression process of the first loading member 11.

[0071] Optionally, the protrusion 1114 is disposed near the far end of the first loading part 111, and multiple protrusions 1114 can be disposed at intervals along the circumference of the first loading part 111, so that the multiple protrusions 1114 can act as stops for the second loading part 112 in multiple different directions.

[0072] In another embodiment, the first loading member 11 includes a first loading part 111 located at the distal end and a second loading part 112 connected to the first loading part 111 and located at the proximal end. The first loading part 111 is sleeved on the outer periphery of the second loading part 112, which is equivalent to the radial dimension of the second loading part 112 not exceeding the inner diameter dimension of the first loading part 111. The first loading part 111 is axially movable relative to the second loading part 112, so that the first loading part 111 and the second loading part 112 can form a coaxial sleeve structure, thereby realizing the axial compression of the first loading member 11.

[0073] Optionally, the first loading part 111 is fitted around the outer periphery of the second loading part 112, that is, the radial dimension of the second loading part 112 located at the proximal end is less than or equal to the inner diameter of the first loading part 111, so that the mounting carrier 1 can accommodate a valve prosthesis with a larger distal radial dimension than the proximal radial dimension.

[0074] In one embodiment, the second loading portion 112 includes a second boss (not shown) facing one end of the first loading portion 111, and the first loading portion 111 includes a second tapered section (not shown) facing one end of the second loading portion 112, the second tapered section being able to engage with the second boss. By providing a second boss at one end of the second loading portion 112 facing the first loading portion 111, and a second tapered section at one end of the first loading portion 111 facing the second loading portion 112, when the first loading member 11 extends its axial length, the second tapered section can engage with the second boss to form a snap-fit ​​connection, thereby reducing the problem of the first loading portion 111 falling off the second loading portion 112.

[0075] like Figure 1 , 2As shown in Figures 5 and 9, in one embodiment, the second loading member 12 includes a plug section 121. The radial dimension of the plug section 121 does not exceed the inner diameter of the second loading part 112. The plug section 121 can be inserted into the second loading part 112, thereby compressing the axial length of the loading carrier 1. At the same time, the proximal end of the second loading part 112 can abut against the outer periphery of the plug section 121 of the second loading member 12, so that the structure of the loading carrier 1 is stable under compression and during the intervention process.

[0076] Optionally, when the carrier 1 is in a compressed state, the insertion section 121 abuts against the proximal end of the first loading part 111. This can compress the axial length of the carrier 1 and improve the structural stability of the carrier 1 under compression, making it easier to retract the carrier 1. During the intervention process, the second loading member 12 and the second loading part 112 are also in abutting state, so that the carrier 1 can be smoothly inserted into the human body.

[0077] In one possible implementation, the second loading member 12 is not provided with a plug-in section 121, that is, the radial dimension of the second loading member 12 is the same as the radial dimension of the second loading part 112, so that the port of the second loading member 12 directly abuts against one end of the second loading part 112.

[0078] Of course, in another embodiment, the second loading member 12 can also be sleeved on the outer periphery of the second loading portion 112, that is, the inner diameter of the second loading member 12 is not less than the radial dimension of the second loading portion 112, so that the second loading member 12 is sleeved on the outer periphery of the second loading portion 112, and after the valve prosthesis is released, the axial length of the mounting carrier 1 can be further compressed. In addition, since the radial dimension of the second loading portion 112 does not exceed the inner diameter of the second loading member 12, the mounting carrier 1 can accommodate a valve prosthesis with a proximal radial dimension larger than the distal radial dimension.

[0079] like Figure 1 and 2 As shown, in one embodiment, the first loading member 11 includes a connecting post 1112 located at the distal end for connection with the adjustment assembly. By providing the connecting post 1112, the adjustment assembly is connected to the connecting post 1112, enabling the adjustment assembly to control the first loading member 11, so that the first loading member 11 can move away from the second loading member 12 to expose the valve prosthesis for easy release, or the adjustment assembly can control the first loading member 11 to move towards the second loading member 12, so that the first loading member 11 is compressed, thereby shortening the axial length of the loading body 1.

[0080] Optionally, the connecting post 1112 is configured to protrude distally.

[0081] Optionally, a connecting post 1112 is provided at the far end of the first loading part 111. The connecting post 1112 is provided with a positioning groove 1111. The adjusting component is located in the positioning groove 1111 and is connected to the first loading part 111.

[0082] like Figure 1 As shown, the second loading member 12 includes a protruding post 122 protruding towards the proximal end, which facilitates the connection between the first connecting member 6 and the second loading member 12. Furthermore, it enables the first connecting pipe 5 to be connected to the second loading member 12 through the first connecting member 6, thereby enabling the first connecting pipe 5 to control the movement of the second loading member 12.

[0083] like Figure 1 , 2 As shown in Figures 7 and 8, in a second aspect, embodiments of this application provide a loading device, including a loading carrier 1 for accommodating a valve prosthesis as provided in the first aspect; the adjusting component includes a support 3, which is connected to the distal end of a first loading member 11 and can drive the first loading member 11 to move away from the second loading member 12, further exposing the valve prosthesis in the loading carrier 1 for easy release; alternatively, after the valve prosthesis is released, the first loading member 11 can be controlled to move towards the second loading member 12, with the second loading member 12 abutting against the first loading member 11, compressing the first loading member 11 to shorten the axial length of the loading carrier 1.

[0084] like Figure 6 As shown, the support member 3 is connected to the distal end of the first loading part 111. The support member 3 can be used to control the movement of the first loading part 111 relative to the second loading part 112, thereby realizing the extension or compression of the first loading part 11, adjusting the axial length of the first loading part 11, and facilitating the retraction of the loading body 1; at the same time, it can also accommodate valve prostheses with different axial lengths.

[0085] Optionally, the support member 3 needs to have a supporting force, that is, a force that can push the first loading part 111 to move axially relative to the second loading part 112. In addition, it also needs to have bending flexibility and shape memory. The support member 3 can be a nickel-titanium tube, nickel-titanium rod, PEEK tube or braided tube, etc.

[0086] like Figures 1 to 3As shown in Figure 6, in one embodiment, the loading device includes a first connecting tube 5, one end of which is connected to the proximal end of the second loading member 12, and the other end is used to connect to a handle. A support member 3 extends within the first connecting tube 5. By providing the first connecting tube 5 and the support member 3 extending within the first connecting tube 5, medical personnel can easily control the second loading member 12 to move toward or away from the first loading member 11, thereby enabling the first loading member 11 and the second loading member 12 to move relative to each other or away from each other, facilitating the compression of the axial length of the loading carrier 1 and the release of the valve prosthesis. In addition, the first loading member 11 and the second loading member 12 can move relative to each other simultaneously, shortening the contraction time of the loading carrier 1, or they can move away from each other simultaneously, shortening the release time of the valve prosthesis, thereby further shortening the operation time.

[0087] like Figure 3 and 6 As shown, in one embodiment, the distal end of the first loading part 111 is provided with a positioning groove 1111. The adjustment assembly also includes a fixing member 2. The support member 3 extends within the loading carrier 1 and penetrates the loading carrier 1 axially. The fixing member 2 is located at the distal end of the support member 3 and is fixedly connected to the support member 3. The fixing member 2 is located in the positioning groove 1111 and abuts against the bottom wall of the positioning groove 1111. The diameter of the support member 3 is relatively small, so the contact area with the first loading part 111 is small. By setting the fixing member 2 and fixing the fixing member 2 to the support member 3, the contact area between the support member 3 and the first loading part 111 is indirectly increased. Moreover, the fixing member 2 is located in the positioning groove 1111, realizing the connection between the support member 3 and the first loading part 111, which facilitates the support member 3 to control the movement of the first loading part 111.

[0088] Optionally, the fastener 2 can be interference-fitted with the positioning groove 1111 to improve the stability between the fastener 2 and the positioning groove 1111.

[0089] In one implementation, the fastener 2 and the support 3 are made of the same material, which facilitates welding or gluing the fastener 2 and the support 3.

[0090] Optionally, the fixing member 2 can be made of nickel-titanium alloy, and the support member 3 can be made of nickel-titanium wire or nickel-iron rod. By utilizing the shape memory function of nickel-titanium alloy, the fixing member 2 and the support member 3 can be fixedly connected by welding and located in the positioning groove 1111. The fixing member 2 can indirectly increase the contact area between the support member 3 and the first loading part 111, while the positioning groove 1111 plays a limiting role for the fixing member 2, making it easier for the support member 3 to control the first loading part 111.

[0091] Of course, when the support 3 is made of non-metallic material, the fastener 2 is made of the same material as the support 3, and the connection can be achieved by adhesive bonding.

[0092] When the support 3 is a nickel-titanium tube or nickel-titanium rod, the fastener 2 can also be a nickel-titanium ring, which can be fitted around the outer periphery of the support 3 for easy welding; when the support 3 is a non-metallic PEEK tube or braided tube, the fastener 2 will also be selected with the same material as the support 3 for easy gluing.

[0093] Of course, the fastener 2 can also be a solid part, that is, one end of the fastener 2 is connected to the end of the support 3 by welding, or it can be connected by adhesive.

[0094] like Figures 1 to 3 As shown in Figure 6, in one embodiment, the adjustment assembly also includes a limiting member 4 connected to the far end of the support member 3. The limiting member 4 is embedded in the positioning groove 1111 and fixedly connected to the first loading part 111. In the axial direction, the fixing member 2 is located at the proximal end of the limiting member 4. The limiting member 4 acts as a stop, thereby reducing the problem of the support member 3 and the fixing member 2 coming out of the positioning groove 1111.

[0095] Optionally, the connection between the limiting member 4 and the far end of the support member 3 may include adhesive bonding or abutment.

[0096] Optionally, the limiting member 4 can also be interference-fitted with the positioning groove 1111 to realize the connection between the limiting member 4 and the first loading part 111. Of course, the limiting member 4 can also be welded to the first loading part 111.

[0097] As one implementation, the first loading member 11 and the limiting member 4 are made of the same material, such as stainless steel, which facilitates welding. Alternatively, they can both be made of PEEK material, which facilitates gluing.

[0098] When the limiting member 4 is made of stainless steel, the fixing member 2 can be made of nickel-titanium or PEEK material. Since these two materials are different, they cannot be directly welded. When the fixing member 2 adopts a ring structure, the fixing member 2 is fixed at the far end of the support member 3, making the far ends of the support member 3 and the fixing member 2 on the same plane. When the limiting member 4 is embedded in the positioning groove 1111 and welded to the first loading part 111, the limiting member 4 can abut against the support member 3 and the fixing member 2, increasing the contact area. The limiting member 4 can limit and stop the support member 3 and the fixing member 2 axially. Alternatively, when both the limiting member 4 and the first loading part 111 are made of PEEK material, the limiting member 4 can be glued to the peripheral wall of the positioning groove 1111. The support member 3 can also be made of PEEK material, and glued to the limiting member 4 to further improve the structural stability between the support member 3 and the limiting member 4. Simultaneously, the fixing member 2 can also be glued to the limiting member 4.

[0099] Optionally, a portion of the limiting member 4 is located in the positioning groove 1111 and abuts against the fixing member 2 and the support member 3, thereby limiting the axial direction of the fixing member 2 and the support member 3. The other portion is located outside the positioning groove 1111 and has a radial dimension larger than the positioning groove 1111, abutting against one end of the positioning groove 1111.

[0100] like Figure 1 and 6 As shown, in one embodiment, the loading device includes a first connector 6, which is located near the end of the second loading member 12 and is connected to the first connecting pipe 5 and the protrusion 122 of the second loading member 12, respectively, to facilitate the connection between the first connecting pipe 5 and the second loading member 12.

[0101] Optionally, the first connector 6 can be made of the same material as the carrier 1, such as stainless steel. In this case, one end of the first connector 6 is welded to the protrusion 122, and the other end is connected to the first connecting pipe 5 by heat fusion. Alternatively, the first connector 6 and the second carrier 12 can both be made of PEEK material, in which case they can be connected to the protrusion 122 by adhesive. The other end can also be connected to the first connecting pipe 5 by heat fusion or adhesive.

[0102] Optionally, the first connector 6 is provided with a heat fusion hole for connecting with the first connecting pipe 5, thereby increasing the contact area between the first connector 6 and the first connecting pipe 5, improving stability, and further enabling the first connecting pipe 5 to control the second loading component 12.

[0103] like Figure 1 , 2 As shown in Figure 7, in one embodiment, the loading device further includes a positioning member 7 for positioning the valve prosthesis connection. The first loading member 11 and the second loading member 12 can move away from the positioning member 7 respectively, so that the positioning member 7 is located axially between the first loading member 11 and the second loading member 12, thereby realizing the detachment of the valve prosthesis from the loading carrier 1 and facilitating the release of the valve prosthesis.

[0104] like Figure 4 and 7 As shown, optionally, the positioning member 7 is provided with a protrusion 71 in the circumferential direction for connecting with the lug of the valve prosthesis. By providing the protrusion 71, it is easy to connect with the valve prosthesis, so as to improve the stability between the valve prosthesis and the positioning member 7.

[0105] Optionally, the number of protrusions 71 can be set to two or three.

[0106] like Figure 1 and 2As shown, in one embodiment, the loading device includes a sleeve 8 connected to the distal end of the positioning member 7. The support member 3 passes through the positioning member 7 and the sleeve 8 in the axial direction. By setting the sleeve 8, the sleeve 8 provides stable support for the support member 3, thereby improving the stability of the support member 3. At the same time, it also improves the concentricity between the support member 3 and the loading carrier 1, reducing the problem of the support member 3 deviating from the axis.

[0107] Optionally, the sleeve 8 can be made of metal, such as stainless steel, or other rigid plastic components.

[0108] As one implementation, the outer surface of the support member 3 is provided with a heat-shrinkable film (not shown in the figure), which can reduce the gap between the support member 3 and the sleeve 8, improve the concentricity between the support member 3 and the sleeve 8, and make the support member 3 and the sleeve 8 coaxial.

[0109] like Figure 1 and 2 As shown, in one embodiment, the loading device includes a second connecting tube 10. One end of the second connecting tube 10 is connected to the proximal end of the positioning member 7, and the other end is used to connect to the handle, so that the second connecting tube 10 can control the positioning member 7 to move within the loading carrier 1, which facilitates the release of the valve prosthesis and improves the convenience of operation.

[0110] like Figure 1 and 2 As shown, optionally, the loading device also includes a second connector 13, which is located near the end of the positioning member 7 and is connected to the second connecting pipe 10 and the positioning member 7 respectively, so as to facilitate the connection between the second connecting pipe 10 and the positioning member 7.

[0111] Optionally, the second connector 13 can be made of the same material as the positioning member 7, such as stainless steel. In this case, one end of the second connector 13 is welded to the positioning member 7, and the other end is connected to the second connecting pipe 10 by heat fusion. Alternatively, the second connector 13 and the positioning member 7 can also be made of PEEK material, in which case they can be connected to the positioning member 7 by adhesive. The other end can also be connected to the second connecting pipe 10 by heat fusion or adhesive.

[0112] Optionally, the second connector 13 is provided with a heat-fusion hole for connecting with the second connecting pipe 10, thereby increasing the contact area between the second connector 13 and the second connecting pipe 10, improving stability, and further enabling the second connecting pipe 10 to control the movement of the positioning member 7.

[0113] Optionally, the first connecting tube 5 and the second connecting tube 10 have a certain degree of flexibility, providing an effective working length for the delivery system to ensure that the valve prosthesis can be positioned in the designated area. The material can be a polymer tubing or a composite tubing composed of a polymer and a metal cutting tube. The polymer material can be nylon elastomer (also known as polyether block amide), nylon, polytetrafluoroethylene, etc., and the metal material can be 304 stainless steel (SUS304), nickel-titanium alloy, etc. The main processing methods are extrusion or thermoforming.

[0114] like Figure 2 , 4 As shown in Figure 6, in one embodiment, the support member 3 extends within the second connecting tube 10. The support member 3 and the second connecting tube 10 have different diameters and a gap exists between them, which facilitates the independent movement of the support member 3 and the second connecting tube 10, reducing the friction between them. A first gap 9 is provided between the support member 3 and the proximal end of the positioning member 7, and the first gap 9 communicates with the gap. The positioning member 7 is provided with an exhaust hole 73, which communicates with the first gap 9. During the operation, air can be vented by injecting liquid between the support member 3 and the second connecting tube 10. The air between the support member 3 and the second connecting tube 10 is discharged through the first gap 9 and the exhaust hole 73 on the positioning member 7, reducing the impact of air on the operation and improving the success rate of the operation.

[0115] Optionally, multiple exhaust ports 73 can be provided to improve exhaust efficiency.

[0116] Optionally, the locating member 7 has a groove along the axial direction at its proximal end, the groove is connected to the exhaust hole 73, and the radial dimension of the groove is larger than the diameter of the support member 3, so that a first gap 9 is formed between the locating member 7 and the support member 3.

[0117] Optionally, the positioning component 7 includes a circular base and a support portion integrally formed with the circular base. The circular base is provided with a plurality of protrusions 71 and notches 72 in the circumferential direction. The support portion is provided with an exhaust hole 73 and a groove is provided along the axial direction of the circular base. The groove communicates with the exhaust hole 73.

[0118] like Figure 1 and 6As shown, in one embodiment, the first connecting tube 5 is sleeved on the outer periphery of the second connecting tube 10, and a second gap 14 is provided between the second connecting tube 10 and the first connecting tube 5. The positioning member 7 has a notch 72 in the circumferential direction, and the notch 72 communicates with the second gap 14. The diameters of the first connecting tube 5 and the second connecting tube 10 are different, so there is a second gap 14 between the first connecting tube 5 and the second connecting tube 10. By providing a notch 72 in the circumferential direction of the positioning member 7, the second gap 14 communicates with the notch 72. During the operation, air can be vented by injecting liquid between the first connecting tube 5 and the second connecting tube 10. The air in the second gap 14 is discharged through the notch 72, reducing the impact of air on the operation and improving the success rate of the operation.

[0119] Optionally, multiple notches 72 can be provided, and the multiple notches 72 are arranged circumferentially along the positioning member 7.

[0120] like Figure 3 As shown, in one embodiment, the loading device includes a guide head 15, which is connected to the first loading part 111. By providing the guide head 15 with a conical structure and a streamlined shape at its tip, the risk of scratching the inner wall of the blood vessel can be reduced, and the entire delivery device can be guided along the blood vessel.

[0121] like Figure 3 As shown, optionally, the guide head 15 is provided with a groove 151 for imaging. By providing a groove 151 on the guide head 15, imaging is facilitated, and the rotation angle of the valve prosthesis can be determined, making it easier for medical staff to position the valve prosthesis.

[0122] like Figure 2 , 3 As shown in Figure 6, in one embodiment, the first loading part 111 includes a protruding connecting post 1112, the connecting post 1112 is provided with a positioning groove 1111; the guide head 15 is provided with a connecting groove at one end facing the connecting post 1112, the connecting post 1112 is fixedly connected to the peripheral wall of the connecting groove, and one end of the limiting member 4 is embedded in the positioning groove 1111, while the other end is tightly connected to the connecting groove, thereby realizing the connection between the guide head 15 and the first loading part 111 and improving the stability of the guide head 15 and the limiting member 4.

[0123] Optionally, the guide head 15 and the first loading part 111 can be connected by threads for easy installation; or they can be glued together.

[0124] Optionally, the limiting member 4 can be interference-fitted with the connecting groove to further improve the stability between the guide head 15 and the limiting member 4.

[0125] Thirdly, embodiments of this application provide a valve prosthesis delivery system, including the loading device provided in the second aspect; it also includes a handle connected to the loading device, the handle being able to control the loading device, thereby realizing the release of the valve prosthesis and the axial shortening of the loading carrier 1 after the valve prosthesis is released.

[0126] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0127] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0128] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A carrier for accommodating a valve prosthesis, characterized in that, The carrier is assembled into the loading device during use. The carrier includes a first loading member and a second loading member, the first loading member being retractable, and the first loading member and the second loading member being movable away from each other to release the valve prosthesis; The first loading component can abut against the second loading component and be compressed axially after the valve prosthesis is released; The second loading component has a chamber for placing a valve prosthesis; The second loading member includes a protruding post located at the proximal end for connection, the protruding post extending in the proximal direction.

2. The carrier according to claim 1, characterized in that, The first loading member includes a first loading part located at the distal end and a second loading part connected to the first loading part and located at the proximal end. The second loading part is sleeved on the outer periphery of the first loading part, and the first loading part is axially movable relative to the second loading part.

3. The carrier according to claim 2, characterized in that, The first loading portion includes a first boss facing one end of the second loading portion, and the second loading portion includes a first tapered section facing one end of the first loading portion, the first tapered section being able to fit against the first boss.

4. The carrier according to claim 3, characterized in that, The outer surface of the first loading part is provided with at least one protrusion to prevent the second loading part from falling off, and the protrusion is located at one end away from the first boss.

5. The carrier according to claim 1, characterized in that, The first loading member includes a first loading part located at the distal end and a second loading part connected to the first loading part and located at the proximal end. The first loading part is sleeved on the outer periphery of the second loading part, and the first loading part is axially movable relative to the second loading part.

6. The carrier according to claim 5, characterized in that, The second loading portion includes a second boss facing one end of the first loading portion, and the first loading portion includes a second tapered section facing one end of the second loading portion, the second tapered section being able to fit against the second boss.

7. The carrier according to any one of claims 2 to 6, characterized in that, The second loading member includes a plug-in section, the radial dimension of which does not exceed the inner diameter of the second loading part, and the plug-in section can be inserted into the second loading part, or; The second loading component is fitted onto the outer periphery of the second loading part.

8. A loading device, characterized in that, Includes the carrier for accommodating a valve prosthesis as described in any one of claims 1 to 7; An adjustment assembly, the adjustment assembly including a support member connected to the distal end of a first loading member, adapted to drive the first loading member to move; The support member is connected to the distal end of the first loading part of the first loading member, and the support member can be used to control the movement of the first loading member relative to the second loading member; the loading device includes a first connecting tube, one end of the first connecting tube is connected to the proximal end of the second loading member, and the other end is used to connect to a handle, and the support member extends within the first connecting tube; The loading device includes a first connector located near the end of the second loading member and connected to the first connecting pipe and the protrusion of the second loading member, respectively.

9. The loading device according to claim 8, characterized in that, The first loading member includes a connecting post located at a distal end for connection with the adjustment assembly; The protrusion of the second loading member is connected to the first connecting member.

10. The loading device according to claim 8, characterized in that, The first loading part has a positioning groove at its distal end. The adjustment component includes a fixing member. The support member passes through the loading body in the axial direction. The fixing member is located at the distal end of the support member and is fixedly connected to the support member. The fixing member is located in the positioning groove and abuts against the bottom wall of the positioning groove.

11. The loading device according to claim 10, characterized in that, The fixing member and the supporting member are made of the same material.

12. The loading device according to claim 10 or 11, characterized in that, The adjustment assembly includes a limiting member connected to the distal end of the support member, the limiting member being embedded in the positioning groove and fixedly connected to the first loading part; in the axial direction, the fixing member is located at the proximal end of the limiting member.

13. The loading device according to claim 12, characterized in that, The limiting component is made of the same material as the first loading component.

14. The loading device according to claim 8, characterized in that, The loading device includes a positioning element for positioning the valve prosthesis connection, and the first loading element and the second loading element are movable in a direction away from the positioning element, such that the positioning element is axially positioned between the first loading element and the second loading element.

15. The loading device according to claim 14, characterized in that, The loading device includes a sleeve connected to the distal end of the positioning member, and the support extends axially through the positioning member and the sleeve.

16. The loading device according to any one of claims 8 to 11, characterized in that, The outer surface of the support is provided with a heat-shrink film.

17. The loading device according to claim 14, characterized in that, The loading device includes a second connecting tube, one end of which is connected to the proximal end of the positioning member, and the other end is used to connect to the handle.

18. The loading device according to claim 17, characterized in that, The support extends inside the second connecting tube and has a gap with the second connecting tube. A first gap is provided between the support and the proximal end of the positioning member, and the first gap communicates with the gap. The positioning member is provided with an exhaust hole, and the exhaust hole communicates with the first gap.

19. The loading device according to claim 18, characterized in that, The first connecting tube is sleeved on the outer periphery of the second connecting tube, and a second gap is provided between the second connecting tube and the first connecting tube. The positioning member has a notch in the circumferential direction, and the notch communicates with the second gap.

20. The loading device according to claim 12, characterized in that, The loading device includes a guide head connected to the first loading part; the first loading part includes a protruding connecting post, and the connecting post is provided with the positioning groove. The guide head has a connecting groove at one end facing the connecting post. The connecting post is threaded to the peripheral wall of the connecting groove. One end of the limiting member is embedded in the positioning groove, and the other end is tightly fitted to the connecting groove.

21. A valve prosthesis delivery system, characterized in that, Includes the loading device as described in any one of claims 8 to 20; A handle, which is connected to the loading device.

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